Senior Manager, Patient Safety Scientist at Bristol-Myers Squibb

Hyderabad, Telangana, India

Apply Now

Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Demonstrates solid capability in utilizing available tools and data sources to investigate safety concerns, contributing to safety assessments with increasing autonomy and analytical insight
Ability to lead SDRMs by reviewing and evaluating clinical data to support signal detection and escalate issues impacting key SMT activities, milestones, and documents
Capability to execute strategy for signal evaluation (e.g., case-series, literature review, health authority/claims databases), promote cross-functional collaboration, author comprehensive signal reports, and manage/track signals within the signal management system
Experience preparing/writing safety and risk management sections of aggregate safety documents (e.g., DSUR, PBRER, PADER)
Proficiency in analyzing data and writing ad hoc responses to health authorities, including supporting local markets
Ability to contribute to preparation/review of safety sections in clinical trial documents (e.g., protocols, CSR, IB, ICF, contraception language), with oversight
Experience representing Patient Safety and supporting safety strategy at internal/external meetings
Capability to execute safety strategy for regulatory filings, including authoring/reviewing safety sections of MAA (e.g., ISS, SCS, clinical overview, briefing documents, labeling)
Skills in analyzing data for ad hoc regulatory safety requests and supporting safety labeling updates
Ability to support EU QPPV or regional/local QP for safety issues
Responsible for creation and update of EDSR, supporting Structured Benefit Risk, defining Company Core Risk Management strategy, and collaborating with Epidemiology

Responsibilities

Performs core signal detection and assessment activities throughout the product life cycle (including review of safety-related literature and quantitative signal detection)
Leads SDRMs by reviewing and evaluating clinical data to support signal detection and escalate issues to the SMT Chair
Executes strategy for signal evaluation, promotes cross-functional collaboration, authors comprehensive signal reports, and proactively manages/tracks signals, ensuring timely stakeholder notification
Prepares/writes safety and risk management sections of aggregate safety documents (e.g., DSUR, PBRER, PADER)
Analyzes data and writes ad hoc responses to health authorities, supporting local markets on risk management queries
Contributes to preparation/review of safety sections in clinical trial documents (e.g., protocols, CSR, IB including RSI, ICF, contraception language), with oversight
Represents Patient Safety and supports safety strategy at internal/external meetings (e.g., pre-submission, Advisory Committees, Scientific Advice, data monitoring committees, publications)
Executes safety strategy for regulatory filings, contributes to key safety messages and risk management approaches, reviews/authors safety sections of MAA (including safety table shells, ISS, SCS, clinical overview, briefing documents, initial labeling)
Contributes to ad hoc regulatory safety requests (e.g., 120-day updates) and analyzes safety data for benefit/risk impact
Analyzes data and authors documentation for safety labeling updates to reflect postmarketing safety profile
Supports EU QPPV or regional/local QP for safety issues on assigned products
Responsible for creation/update of EDSR to characterize emerging safety concerns, support Structured Benefit Risk, define risk management strategy, gain SMT/governance alignment, and collaborate with Epidemiology on risk minimization effectiveness

Skills

Key technologies and capabilities for this role

Signal DetectionSafety SurveillancePharmacovigilanceRisk ManagementDSURPBRERPADERClinical Data AnalysisSignal ManagementLiterature ReviewQuantitative AnalysisAggregate Safety Reports

Questions & Answers

Common questions about this position

What benefits does Bristol Myers Squibb offer?

Bristol Myers Squibb offers a wide variety of competitive benefits, services, and programs that provide employees with resources to pursue their goals both at work and in their personal lives.

Is this a remote position or does it require office work?

This information is not specified in the job description.

What are the main responsibilities or skills needed for this role?

The role involves performing signal detection and assessment activities, leading safety data review meetings, executing signal evaluation strategies, preparing safety sections for aggregate documents and clinical trial materials, and supporting regulatory filings.

What is the company culture like at Bristol Myers Squibb?

The culture is challenging, meaningful, and life-changing, with uniquely interesting work, opportunities to grow alongside high-achieving teams, and emphasis on balance and flexibility.

What makes a strong candidate for this Senior Manager position?

A strong candidate demonstrates solid capability in signal detection tools and data sources, ability to lead safety review meetings, execute signal evaluation strategies with cross-functional collaboration, and experience authoring safety documents for regulatory submissions.

Bristol-Myers Squibb

Develops and delivers biopharmaceutical medicines

About Bristol-Myers Squibb

Bristol Myers Squibb (BMS) develops and delivers medicines aimed at treating serious diseases, focusing on areas like cancer, autoimmune diseases, and heart conditions. The company conducts extensive research and development to create new drugs, which are sold after receiving regulatory approval. BMS also produces generic drugs, offering affordable alternatives that meet the same quality standards as their branded counterparts. What sets BMS apart from competitors is its dual focus on both innovative and generic medicines, enhancing access to healthcare. The company's goal is to improve patient outcomes while maintaining a commitment to sustainability and corporate responsibility.

New York City, New YorkHeadquarters

1887Year Founded

$33,706.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Flexible Work Hours

Hybrid Work Options

Professional Development Budget

Risks

Increased competition in oncology from emerging biotech firms like ArsenalBio.

BMS's lawsuit over the 340B Drug Pricing Program may lead to regulatory challenges.

Rapid AI and digital tech evolution may pose integration challenges for BMS.

Differentiation

BMS focuses on innovative cancer treatments through collaborations like ArsenalBio for T cell therapies.

The company emphasizes digital health technologies, enhancing clinical trial management and patient engagement.

BMS offers both innovative and generic medicines, increasing affordable healthcare solutions.

Upsides

BMS's partnership with Medidata enhances clinical research processes and patient outcomes.

The collaboration with AI Proteins advances novel miniprotein-based therapeutics, expanding therapeutic modalities.

BMS's global license agreement with BioArctic expands its portfolio in neurodegenerative diseases.

Land your dream remote job 3x faster with AI

Try Jobo Free